The European Commission has granted marketing authorization for Dengvaxia®, Sanofi’s dengue vaccine.
The marketing authorization follows the October 18, 2018, recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to approve use of the dengue vaccine in European endemic areas.
Dengvaxia® will be available in Europe to prevent dengue disease in individuals 9-45 years of age with a documented prior dengue infection and who are living in endemic areas.
“In some of the European overseas territories where dengue recurs regularly, people who have had a dengue infection previously are at risk of being infected with the virus again,” explains Dr. Su-Peing Ng, Global Medical Head at Sanofi Pasteur, the vaccine unit of Sanofi. “As the second infection with dengue tends to be more severe than the first, it is important to be able to offer these people a vaccine that could help protect them against subsequent dengue infections.”
The dengue vaccine has been evaluated in studies involving more than 40,000 people from 15 countries with up to six years of follow-up from large-scale clinical safety and efficacy investigations.
Dengue fever is a mosquito-borne infection that people can get up to 4 times in a lifetime. Dengue is also known as ‘break-bone fever’ since it can cause debilitating disease marked by prolonged episodes of high fever and severe joint pain. An infection can progress unpredictably to a life-threatening form of the disease called dengue hemorrhagic fever that often requires hospitalized care. Today, there is no specific treatment available for dengue.